The FDA ordered Emergent BioSolutions to pause vaccine production while they work together to address "potential quality issues."
"The FDA cited a number of observations concerning whether the facility’s processes met our requirements and standards," the FDA wrote in a statement.
The FDA hasn't authorized the manufacture or distribution of J&J vaccine components at the facility and none of the CCP (Chinese Communist Party) virus vaccines produced there have been distributed in the United States so far.
The FDA will test and evaluate them before potential distribution.
"Johnson & Johnson will exercise its oversight authority to ensure that all of FDA’s observations are addressed promptly and comprehensively. The Company will also redouble its efforts as it continues to work toward securing Emergency Use Authorization in the United States for drug substance manufactured at Emergent Bayview as quickly as possible," the company stated.
The vaccine adverse event reporting system (VAERS) received 3,005 reports of deaths among people in the United States who had received one of the COVID-19 shots between Dec. 14, 2020, and April 12, 2021. More than 189 million doses of the shot were delivered during this time.
Emergent BioSolutions didn't respond to a request for comment by press time.